NCT01052285

Brief Summary

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

January 19, 2010

Last Update Submit

November 17, 2011

Conditions

Hernia

Keywords

Transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

  • Pain scores by coughing between TAP block group and placebo group

    Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,19,24 hours postoperative

    0,2,4,6,8,19 and 24 hours postoperative

Secondary Outcomes (5)

  • Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.

    0,2,4,6,8,19 and 24 hours postoperative

  • Total opioid consumption

    0-24 hours postoperative

  • Postoperative nausea and vomiting

    0,2,4,6,8,19,24 hours postoperative

  • Sedation

    0,2,4,6,8,19,24 hours postoperative

  • Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo

    0,2,4,6,8,19,24 hours postoperative

Study Arms (3)

Placebo

PLACEBO COMPARATOR

TAP block with 25 ml of saline Ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline.

Procedure: Saline

Local infiltration

ACTIVE COMPARATOR

Ilioinguinal block with 10 ml of ropivacaine 0,375% Local infiltration with 40 ml of ropivacaine 0,375% Tap block with 25 ml of saline

Procedure: Local infiltration

Transversus abdominis plane block

EXPERIMENTAL

25 ml of Ropivacaine 0,75%, Ilioinguinal block with 10 ml saline and local infiltration with 40 ml of saline.

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane blockPROCEDURE

UL-guided TAP block with 25 ml of ropivacaine 0,75% unilateral, single dose, ilioinguinal block with 10 ml of saline and local infiltration with 40 ml of saline

Also known as: postoperative pain, UL-guided block
Transversus abdominis plane block
SalinePROCEDURE

UL-guided Tap block with 25 ml of saline single dose Ilioinguinal block with 10 ml of saline and local infiltration with saline 40 ml single dose

Also known as: postoperative pain.
Placebo
Local infiltrationPROCEDURE

Ilioinguinal block with 10 ml of ropivacaine 0,375% single dose, local infiltration with 40 ml of ropivacaine 0,375% single dose, UL-guided Tap block with 25 ml of saline single dose

Also known as: Local wound infiltration
Local infiltration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • groin hernia repair
  • written consent
  • ASA 1-3
  • BMI 18-35

You may not qualify if:

  • unable to communicate in Danish
  • relevant drug allergy
  • pain medication in the last 24 hours
  • pregnancy
  • alcohol or/and drug abuse
  • daily opioid intake
  • infection at injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Glostrup university hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

    PMID: 23549122DERIVED

MeSH Terms

Conditions

Hernia

Interventions

Sodium ChlorideAnesthesia, Local

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Pernille L Petersen, MD

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

DK(1)